The following data is part of a premarket notification filed by Action Eyewear Corp. with the FDA for Action Medtek Face Shield.
| Device ID | K926438 |
| 510k Number | K926438 |
| Device Name: | ACTION MEDTEK FACE SHIELD |
| Classification | Accessory, Surgical Apparel |
| Applicant | ACTION EYEWEAR CORP. 1401 DUFF DRIVE, UNIT 100 Fort Collin, CO 80524 |
| Product Code | LYU |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-23 |
| Decision Date | 1993-08-18 |